Faecal IncontinenceNCT04749316
Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
A study testing AcuTENS in people with Faecal Incontinence and Faecal Incontinence With Faecal Urgency, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Faecal Incontinence, Faecal Incontinence With Faecal Urgency, Neuromodulation
- What is being tested?
- AcuTENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or above
- Acupuncture naïve patients
- Faecal incontinence with solid or liquid stool causing disruption of lifestyle
- Psychological stability and suitability as determined by the investigator
- Failed conservative or surgical treatment
- Intact peripheral neurosensory nervous system as determined by clinical investigation
- Able to read and write
Who cannot join
- Major internal and/or external sphincter defect (>120 degrees of sphincter circumference)
- Faecal impaction
- Presence of full thickness rectal prolapse
- Patients who have contact allergies to adhesive pads
- Implanted pacemaker, defibrillator, cardiopathy
- Pregnancy or intention to become pregnant
Show all 10Show fewer
- Neurogenic or congenital disorders resulting in faecal incontinence (e.g. Multiple Sclerosis, uncontrolled diabetes, Parkinson's disease, Spina Bifida)
- Inflammatory bowel disease
- Chronic diarrhoea uncontrolled by medication or diet
- Previous rectal surgery (rectopexy or rectal resection)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Read the detailed description
Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum. Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is under-reported by patients.
Conservative management of FI involves lifestyle, medical adjustments and pelvic floor sphincter training. If conservative treatment fails, surgical options such as sphincter repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can be reformed. SNM and PTNS involve application of nervous electrical stimulation (neuromodulation) with significant improvement of symptoms. The positions of electrical stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese Medicine for the treatment of faecal incontinence. However, disadvantage of these methods are; 1) they are invasive and may cause complications such as pain, infection and bleeding and; 2) the devices for each SNM device can be costly.
Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used for the management of pain. It works via the application of electrical stimuli using adhesive gel pads. They are cheap to run and are widely accepted by patients. Hence application of TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.
A randomised controlled trial will be carried out on patients with FI. Demographic data, past medical history, in particular any structural or neurological causes of FI, will be recorded. Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment. Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup intervals.
- Conditions
- Faecal Incontinence, Faecal Incontinence With Faecal Urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation, Acupuncture Points
- Being tested
- AcuTENS
- Keywords
- Faecal incontinence, Faecal urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation, Acupuncture
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcuTENSProcedure or surgery
Stimulation of acupuncture points with TENS machine
| Study group | Role | What they receive |
|---|---|---|
| AcuTENS | Experimental | Patients treated with TENS over Acupuncture points for faecal incontinence Receives: Procedure: AcuTENS |
| Sham | Sham comparator | Sham treatment arm with no electrical stimulations over acupuncture points Receives: Procedure: AcuTENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
Measured: post treatment 8 weeks and 6 months compared with baseline
Secondary outcomes (4)
Changes in the severity of faecal incontience
Wexner score will be used the assess the severity of faecal incontinence
Measured: post treatment 8 weeks and 6 months compared with baseline
Episodes of faecal urgency per week
the number of episodes of faecal urgency experienced by the patient per week
Measured: post treatment 8 weeks and 6 months compared with baseline
Reduction in the number of incontinence episode per week
the number of episodes of faecal incontience experienced by the patient per week
Measured: post treatment 8 weeks and 6 months compared with baseline
Differences in Quality of Life score between two groups
using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL)
Measured: post treatment 8 weeks and 6 months compared with baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Aug 2017
- Primary completion30 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Acutens treatment for faecal incontinence vs sham
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Tony Wing Chung Mak, Chinese University of Hong Kong
- Investigators
- Tony WC Mak, MD, FRCS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749316
- Sponsor's protocol ID
- HMRF13140421
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
- ClinicalTrials.gov ID
- NCT04749316
- Acronym / sponsor ID
- HMRF13140421
- Conditions
- Faecal Incontinence, Faecal Incontinence With Faecal Urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation, Acupuncture Points
- Keywords
- Faecal incontinence, Faecal urgency, Neuromodulation, Transcutaneous Electric Nerve Stimulation, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Detailed description
Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum. Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is under-reported by patients.
Conservative management of FI involves lifestyle, medical adjustments and pelvic floor sphincter training. If conservative treatment fails, surgical options such as sphincter repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can be reformed. SNM and PTNS involve application of nervous electrical stimulation (neuromodulation) with significant improvement of symptoms. The positions of electrical stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese Medicine for the treatment of faecal incontinence. However, disadvantage of these methods are; 1) they are invasive and may cause complications such as pain, infection and bleeding and; 2) the devices for each SNM device can be costly.
Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used for the management of pain. It works via the application of electrical stimuli using adhesive gel pads. They are cheap to run and are widely accepted by patients. Hence application of TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.
A randomised controlled trial will be carried out on patients with FI. Demographic data, past medical history, in particular any structural or neurological causes of FI, will be recorded. Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment. Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Acutens treatment for faecal incontinence vs sham
| Arm | Type | Receives |
|---|---|---|
| AcuTENS | Experimental | Procedure: AcuTENSPatients treated with TENS over Acupuncture points for faecal incontinence |
| Sham | Sham comparator | Procedure: AcuTENSSham treatment arm with no electrical stimulations over acupuncture points |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or above
- Acupuncture naïve patients
- Faecal incontinence with solid or liquid stool causing disruption of lifestyle
- Psychological stability and suitability as determined by the investigator
- Failed conservative or surgical treatment
Key exclusion criteria (10 listed)
- Major internal and/or external sphincter defect (>120 degrees of sphincter circumference)
- Faecal impaction
- Presence of full thickness rectal prolapse
- Patients who have contact allergies to adhesive pads
- Implanted pacemaker, defibrillator, cardiopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcuTENSStimulation of acupuncture points with TENS machine | Procedure or surgery | AcuTENS, Sham |
Primary outcome
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Time frame: post treatment 8 weeks and 6 months compared with baseline
Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
4 secondary outcomes
Changes in the severity of faecal incontience
Time frame: post treatment 8 weeks and 6 months compared with baseline
Episodes of faecal urgency per week
Time frame: post treatment 8 weeks and 6 months compared with baseline
Reduction in the number of incontinence episode per week
Time frame: post treatment 8 weeks and 6 months compared with baseline
Differences in Quality of Life score between two groups
Time frame: post treatment 8 weeks and 6 months compared with baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony WC Mak, MD, FRCS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcuTENS in people with Faecal Incontinence and Faecal Incontinence With Faecal Urgency, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention (time frame: post treatment 8 weeks and 6 months compared with baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.